This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.
FDA GUIDANCE DOCUMENT: Clinical Decision Support Software!
Guidance for Industry and Food and Drug Administration Staff.
January 2026